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Tissue Characterisation by Endoscopic GI-elastography

NCT ID: NCT01360411

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-07-31

Brief Summary

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In this single centre study we study the use of endoscopic ultrasonography (EUS) combined with elastography in order to separate malignant tissue from benign tissue in and adjacent to the upper gastrointestinal tract.

Detailed Description

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The purpose of this study is to use endoscopic ultrasonography (EUS) with strain based elastography to identify strain traits separating malignant from benign lesions. We are registering feasibility of endoscopic strain imaging and compare diagnostic accuracy of EUS + elastography with previous data on EUS alone.

Inclusion criteria:

* Group 1: Focal subepithelial lesions in esophageal, ventricular or duodenal wall discovered by endoscopy or other imaging modality.
* Group 2: Pancreatic lesion discovered by other imaging modality.
* Group 3: Mediastinal or retroperitoneal lymph node or tumor discovered by other imaging modality.

Histology of lesions should not be known at the time of examination. EUS elastography findings are evaluated shortly after the examination and categorised by different methods; categorical score, VAS, Strain Ratio. The result is then compared to histology or cytology results. Patients who do not undergo tissue sampling are followed up to discover disease progress.

Conditions

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Disorder of Upper Gastrointestinal Tract Pancreatic Nodule Secondary and Unspecified Malignant Neoplasm of Retroperitoneal Lymph Nodes Secondary Malignant Neoplasm of Lymph Node

Keywords

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elastography strain ratio pancreas GI wall lesions lymph nodes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatic lesions

Any patient with a solid pancreatic lesion of unknown histology may be recruited. Cystic lesions are not included.

Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively.

No interventions assigned to this group

Intramural upper GI-lesions

Patients with intramural lesions discovered by endoscopy or other imaging modalities are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively.

No interventions assigned to this group

Lymph nodes

Patients with visible mediastinal lymph nodes or retroperitoneal lymph nodes in patients with inflammatory or malignant diseases are recruited. Elastography findings are classified and compared to cytology or histology if the standard procedures or treatment provide this. In other cases the patients are being followed up conservatively.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Solid focal lesions in pancreas or pancreatitis
* Intramural lesions in esophagus, ventricle or duodenum
* Lymph nodes or tumour \> 1 cm in mediastinum or retroperitoneum accessible by EUS

Exclusion Criteria

* Cystic pancreatic lesions
* Patients where the histology or cytology of the lesion in question is known at the time of examination
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Roald Flesland Havre

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Birger Nesje, MD, PhD

Role: STUDY_DIRECTOR

University of Bergen

Roald F. Havre, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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Haukeland University Hospital/University of Bergen

Bergen, , Norway

Site Status

Countries

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Norway

References

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Waage JE, Havre RF, Odegaard S, Leh S, Eide GE, Baatrup G. Endorectal elastography in the evaluation of rectal tumours. Colorectal Dis. 2011 Oct;13(10):1130-7. doi: 10.1111/j.1463-1318.2010.02440.x.

Reference Type BACKGROUND
PMID: 21040360 (View on PubMed)

Havre RF, Elde E, Gilja OH, Odegaard S, Eide GE, Matre K, Nesje LB. Freehand real-time elastography: impact of scanning parameters on image quality and in vitro intra- and interobserver validations. Ultrasound Med Biol. 2008 Oct;34(10):1638-50. doi: 10.1016/j.ultrasmedbio.2008.03.009. Epub 2008 Jun 4.

Reference Type BACKGROUND
PMID: 18524458 (View on PubMed)

Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich C, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study. Endoscopy. 2011 Jul;43(7):596-603. doi: 10.1055/s-0030-1256314. Epub 2011 Mar 24.

Reference Type BACKGROUND
PMID: 21437851 (View on PubMed)

Havre RF, Waage JR, Gilja OH, Odegaard S, Nesje LB. Real-Time Elastography: Strain Ratio Measurements Are Influenced by the Position of the Reference Area. Ultraschall Med. 2012 Dec;33(6):559-568. doi: 10.1055/s-0031-1273247. Epub 2011 Jun 10.

Reference Type BACKGROUND
PMID: 21667433 (View on PubMed)

Saftoiu A, Vilmann P, Gorunescu F, Janssen J, Hocke M, Larsen M, Iglesias-Garcia J, Arcidiacono P, Will U, Giovannini M, Dietrich CF, Havre R, Gheorghe C, McKay C, Gheonea DI, Ciurea T; European EUS Elastography Multicentric Study Group. Efficacy of an artificial neural network-based approach to endoscopic ultrasound elastography in diagnosis of focal pancreatic masses. Clin Gastroenterol Hepatol. 2012 Jan;10(1):84-90.e1. doi: 10.1016/j.cgh.2011.09.014. Epub 2011 Oct 1.

Reference Type RESULT
PMID: 21963957 (View on PubMed)

Other Identifiers

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17765

Identifier Type: -

Identifier Source: org_study_id